Asthma
Conditions
Keywords
Asthma
Brief summary
A Safety, Efficacy, and Tolerability Study of Daily Dosing with Levalbuterol Tartrate HFA MDI and Placebo in Subjects Aged Birth to \<48 Months with Asthma.
Detailed description
This is a modified-blind, randomized, placebo-controlled, multicenter, parallel-group trial of levalbuterol HFA MDI administered using a facemask and holding chamber in subjects birth to \<48 months with asthma. This study was previously posted by Sepracor Inc. In October 2009, Sepracor Inc. was acquired by Dainippon Sumitomo Pharma., and in October 2010, Sepracor Inc's name was changed to Sunovion Pharmaceuticals Inc.
Interventions
DRUGLevalbuterol
90 ug Levalbuterol (2 actuations)
DRUGLevalbuterol UDV TID
0.31 ug Levalbuterol UDV TID
DRUGPlacebo
Placebo (2 actuations)
Sponsors
Sumitomo Pharma America, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
No minimum to 48 Months
Healthy volunteers
No
Inclusion criteria
* Subject's parent/legal guardian must give written informed consent, including privacy authorization, prior to study participation. Complete documentation regarding the consent process must be recorded in the case report form (CRF) and source documentation. * Subject's parent/legal guardian must be willing and able to comply with the study procedures and visit schedules. * Subject, male or female, must be between the ages of birth and \<48 months, exclusive, at the time of consent. * Subjects 24 to \<48 months of age must have a history of physician-diagnosed asthma (defined as at least 3 episodes of respiratory symptoms consistent with asthma symptoms including, but not limited to, cough, wheeze, or dyspnea). * Subjects 0 to \<24 months of age must have a history of 3 episodes of respiratory symptoms that in the judgement of the investigator could be consistent with asthma or reactive airways disease. * Subject must be in good health and not affected by any other chronic conditions, including respiratory disorders other than asthma. * In subjects with a chest radiograph (taken 12 months prior to screening visit), no evidence of any chronic cardiopulmonary condition other than asthma should be present as discerned by the Investigator. * Subject's parent/legal guardian must be able to complete the diary cards and medical event calendars (MEC) reliably on a daily basis and understand dosing instructions and questionnaire completion.
Exclusion criteria
* Subject who requires or is expected to require any disallowed medications * Subject who has participated in an investigational drug study within 30 days prior to screening, or who is currently participating in another clinical trial. * Subject or parent/legal guardian who has daily commitments during the study that would interfere with trial measurements, compliance, or both. * Subject who has a history of hospitalization for asthma, reactive airways disease, or bronchospasm within 4 weeks prior to screening or who is scheduled for in-patient hospitalization, including elective surgery during the course of the trial. * Subject who has experienced significant blood loss within 60 days of study drug. * Subject with a clinical diagnosis of cystic fibrosis. * Subject who was born prematurely, defined as less than 38 weeks gestational age at birth, and is \<1 year of age at screening * Subject whose body weight is less than 7.0 kg at screening. This minimum weight requirement is based upon standard pediatric growth charts \[CDC 2000\]. * Subject with a known sensitivity to levalbuterol or racemic albuterol, or any of the excipients contained in any of these formulations. * Subject using any prescription drug with which levalbuterol or racemic albuterol sulfate administration is contraindicated. * Subject with a history of life-threatening asthma, defined as previous asthma episodes requiring intubation or associated with hypercapnia, respiratory arrest, or hypoxic seizures. * Subject with clinically significant abnormalities that may interfere with the metabolism or excretion of the study drugs or study participation (eg, abnormalities of renal, hepatic, metabolic, or endocrine function). * Subject with a history of cancer. * Subject with any chronic or congenital cardiorespiratory condition other than asthma including, but not limited to, bronchopulmonary dysplasia, congenital heart disease, and cystic fibrosis. * Subject affected by an upper or lower respiratory tract infection in the 3 weeks prior to screening. * Subject with a history of ventilation for a respiratory condition occurring at or near birth, including those associated with prematurity or bronchopulmonary dysplasia. Ventilatory support for elective non-cardiopulmonary surgery is not exclusionary. - Subject with any clinically significant abnormal laboratory values (hematology, blood chemistry). * Subject with a clinically significant abnormal 12-lead ECG that would put the subject at risk for experiencing adverse cardiac effects. * Subject who is a relative of a staff member.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline to Visit 4 in the Mean Daily Composite Score Based on the Pediatric Asthma Caregiver Assessments (PACA) | Baseline, Visit 4 (Week 4) | The daily composite score is the sum of the scores of 5 domains: Nocturnal Awakenings Due to Wheeze and Cough, Daytime Wheeze, Daytime Cough, Shortness of Breath, and Asthma Symptom Score. A possible score of 0 (no symptoms) to 19 (severe symptoms). The mean daily composite score at Visit 4 is defined as the mean of the daily composite scores in the week prior to Visit 4. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline to Visit 2 to Visit 3 in the Mean Daily Composite Score Based on the Pediatric Asthma Caregiver Assessment | The days from Visit 2 (inclusive) to the day prior to Visit 3 - approximately 14 days | The daily composite score is the sum of the scores of 5 domains: Nocturnal Awakenings Due to Wheeze and Cough, Daytime Wheeze, Daytime Cough, Shortness of Breath, and Asthma Symptom Score. A possible score of 0 (no symptoms) to 19 (severe symptoms). The mean daily composite score from Visit 2 to Visit 3 is defined as the mean of the daily composite scores from Visit 2 (inclusive) to the day prior to Visit 3. |
| Change From Baseline to Visit 3 to Visit 4 in the Mean Daily Composite Score Based on the Pediatric Asthma Caregiver Assessment | The days from Visit 3 (inclusive) to the day prior to Visit 4 - approximately 14 days | The daily composite score is the sum of the scores of 5 domains: Nocturnal Awakenings Due to Wheeze and Cough, Daytime Wheeze, Daytime Cough, Shortness of Breath, and Asthma Symptom Score. A possible score of 0 (no symptoms) to 19 (severe symptoms). The mean daily composite score from Visit 3 to Visit 4 is defined as the mean of the daily composite scores from Visit 3 (inclusive) to the day prior to Visit 4. |
| Change From Baseline to Visit 3 in the Mean Daily Composite Score Based on the Daytime and Nighttime Asthma Symptom Scores as Measured by the Pediatric Asthma Questionnaire (PAQ) | Baseline, Visit 3 (Week 3) | The daily composite score is the sum of the scores of 7 items: Difficulty Breathing, Cough, Wheeze, Activity Limitation, Level of Activity Limitation, Overall Symptom Score, and Nighttime Asthma. The range for the PAQ is 0 (no symptoms) to 27 (severe symptoms). The mean daily composite score at Visit 3 is defined as the mean daily composite scores for 7 days prior to Visit 3. |
| Change From Baseline to Visit 4 in the Mean Daily Composite Score Based on the Daytime and Nighttime Asthma Symptom Scores as Measured by Pediatric Asthma Questionnaire | Baseline, Visit 4 (Week 4) | The daily composite score is the sum of the scores of 7 items: Difficulty Breathing, Cough, Wheeze, Activity Limitation, Level of Activity Limitation, Overall Symptom Score, and Nighttime Asthma. The range for the PAQ is 0 (no symptoms) to 27 (severe symptoms). The mean daily composite score at Visit 4 is defined as the mean daily composite scores in the 7 days prior to Visit 4. |
| Change From Baseline to Visit 2 to Visit 3 in the Mean Daily Composite Score Based on the Daytime and Nighttime Asthma Symptom Scores as Measured by the Pediatric Asthma Questionnaire | The days from Visit 2 (inclusive) to the day prior to Visit 3 - approximately 14 days | The daily composite score is the sum of the scores of 7 items: Difficulty Breathing, Cough, Wheeze, Activity Limitation, Level of Activity Limitation, Overall Symptom Score, and Nighttime Asthma. The range for the PAQ is 0 (no symptoms) to 27 (severe symptoms). The mean daily composite score from Visit 2 to Visit 3 is defined as the mean of the daily composite scores from Visit 2 (inclusive) to the day prior to Visit 3. |
| Change From Baseline to Visit 3 to Visit 4 in the Mean Daily Composite Score Based on the Daytime and Nighttime Asthma Symptom Score as Measured by the Pediatric Asthma Questionnaire | The days from Visit 3 (inclusive) to the day prior to Visit 4 - approximately 14 days | The daily composite score is the sum of the scores of 7 items: Difficulty Breathing, Cough, Wheeze, Activity Limitation, Level of Activity Limitation, Overall Symptom Score, and Nighttime Asthma. The range for the PAQ is 0 (no symptoms) to 27 (severe symptoms). The mean daily composite score from Visit 3 to Visit 4 is defined as the mean of the daily composite scores from Visit 3 (inclusive) to the day prior to Visit 4. |
| Change From Baseline in In-Clinic Peak Expiratory Flow to Postdose Timepoints at Visit 2 | Baseline, Visit 2: 30 minutes post-dose (on the day of randomization), 1 hour post-dose, 4 hours post-dose, 6 hours post-dose | Peak expiratory flow (PEF) measures how fast a person can breathe out using the greatest effort |
| Change From Baseline in In-Clinic Peak Expiratory Flow to Postdose Timepoint at Visit 3 | Baseline, Visit 3, pre-dose (approximately 14 days after randomization) | — |
| Change From Baseline in In-Clinic Peak Expiratory Flow to Postdose Timepoint at Visit 4 | Visit 4: pre-dose (approximately 28 days after randomization) , 30 minutes post-dose, 1 hour post-dose, 4 hours post-dose, 6 hours post-dose | — |
| Percent Change From Baseline in In-Clinic Peak Expiratory Flow to Postdose Timepoints at Visit 2 | Baseline, Visit 2: , 30 minutes post-dose (on the day of randomization), 1 hour post-dose, 4 hours post-dose, 6 hours post-dose | — |
| Percent Change From Baseline in In-Clinic Peak Expiratory Flow to Postdose Timepoints at Visit 3 | Baseline, Visit 3, pre -dose (approximately 14 days after randomization) | — |
| Percent Change From Baseline in In-Clinic Peak Expiratory Flow to Postdose Timepoints at Visit 4 | Baseline, Visit 4, pre -dose (approximately 28 days after randomization) | — |
| Change From Baseline to Visit 3 in Mean Daily Composite Score Based on the Pediatric Asthma Caregiver Assessment | Baseline, Visit 3 (Week 3) | The daily composite score is the sum of the scores of 5 domains: Nocturnal Awakenings Due to Wheeze and Cough, Daytime Wheeze, Daytime Cough, Shortness of Breath, and Asthma Symptom Score. A possible score of 0 (no symptoms) to 19 (severe symptoms). The mean daily composite score at Visit 3 is defined as the mean of the daily composite scores in the 7 days prior to Visit 3. |
| Percent Change From Baseline in the At-Home Mean Daily Peak Expiratory Flow (PEF to Postdose Timepoint at Visit 3 and Visit 4) | Visit 3 (the week prior to Visit 3), Visit 4 (the week prior to Visit 4) | Mean of the daily pre-dose PEF values in the week prior to visit in those subjects aged 24 to \<48 months capable of performing acceptable and reproducible PEF maneuvers. |
| Investigator Global Assessment - Question 1 | Visit 4 (End of 28 day treatment period) | Since the start of the study, how would you evaluate the child's asthma symptoms? |
| Investigator Global Assessment - Question 2 | Visit 4 (End of 28 day treatment period) | Since the start of the study, how would you evaluate your ability to manage the subject's asthma? |
| Caregiver Global Assessment - Question 1 | Visit 4 (End of 28 day treatment period) | Since the start of the study, how would you evaluate your child's asthma symptoms? |
| Caregiver Global Assessment - Question 2 | Visit 4 (End of 28 day treatment period) | Since the start of the study, how would you evaluate your ability to manage your child's asthma? |
| Caregiver Global Assessment - Question 3 | Visit 4 (End of 28 day treatment period) | Overall I was: Very satisfied with the control of the child's asthma symptoms while enrolled in this study, Moderately satisfied with the control of the child's asthma symptoms while enrolled in this study, Slightly satisfied with the control of the child's asthma symptoms while enrolled in this study, Not satisfied with the control of the child's asthma symptoms while enrolled in this study or answer Missing |
| Rescue Medication Use: Number of Subjects Using Rescue Medication During the Treatment Period | Visit 2 to Visit 3 (the first 2 weeks of the study) , Visit 3 to Visit 4 (the second 2 weeks of the study), Visit 2 to Visit 4 (the entire 4 weeks of the study) | Number of subjects using rescue medication during the treatment period |
| Rescue Medication Use - Change From Baseline in Mean Number of Days Used Per Week When Used | Visit 2 to Visit 3 (the first 2 weeks of the study) , Visit 3 to Visit 4 (the second 2 weeks of the study), Visit 2 to Visit 4 (the entire 4 weeks of the study) | — |
| Rescue Medication Use - Change From Baseline in Mean Number of Doses Used Per Week | Visit 2 to Visit 3 (the first 2 weeks of the study) , Visit 3 to Visit 4 (the second 2 weeks of the study), Visit 2 to Visit 4 (the entire 4 weeks of the study) | — |
| Rescue Medication Use - Change From Baseline in Mean Number of Doses Used Per Week During Weeks When Used | Visit 2 to Visit 3 (the first 2 weeks of the study), Visit 3 to Visit 4 (the second 2 weeks of the study), Visit 2 to Visit 4 (the entire 4 weeks of the study) | — |
| Change From Baseline to Visit 3 and Visit 4 in the Pediatric Asthma Caregiver's Quality of Life Questionnaire (PACQLA) Composite Score | Visit 3 and Visit 4 (End of 28 day treatment period) | The PACQLQ composite score was calculated as the mean of the scores of the 13 individual questions. Composite scores could range from 1 to 7. Lower scores indicated greater impact of disease on quality of life. |
| Change From Baseline in the At-Home Mean Daily Peak Expiratory Flow (PEF to Postdose Timepoint at Visit 3 and Visit 4 | Baseline, Visit 3 (the week prior to Visit 3) and Visit 4 | Mean of the daily pre-dose PEF values in the week prior to visit in those subjects aged 24 to \<48 months capable of performing acceptable and reproducible PEF maneuvers. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Placebo Placebo Placebo MDI TID | 68 |
| Levalbuterol MDI Levalbuterol MDI TID | 65 |
| Levalbuterol UDV Levalbuterol UDV TID: 0.31 ug Levalbuterol UDV TID | 63 |
| Total | 196 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Adverse Event | 2 | 3 | 3 |
| Overall Study | Lost to Follow-up | 0 | 0 | 1 |
| Overall Study | Noncompliance with Medication | 0 | 0 | 1 |
| Overall Study | Protocol Violation | 1 | 1 | 1 |
| Overall Study | Subject Uncooperative | 1 | 0 | 2 |
| Overall Study | Withdrawal by Subject | 2 | 1 | 3 |
Baseline characteristics
| Characteristic | Levalbuterol MDI | Levalbuterol UDV | Placebo | Total |
|---|---|---|---|---|
| Age, Categorical <=18 years | 65 Participants | 63 Participants | 68 Participants | 196 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Continuous | 29.3 Months STANDARD_DEVIATION 12.57 | 28.4 Months STANDARD_DEVIATION 12.48 | 29.2 Months STANDARD_DEVIATION 12.17 | 29.0 Months STANDARD_DEVIATION 12.35 |
| Age, Customized 0 to < 12 months | 9 participants | 9 participants | 9 participants | 27 participants |
| Age, Customized 0 to < 24 months | 23 participants | 22 participants | 23 participants | 68 participants |
| Age, Customized 24 to < 48 months | 42 participants | 41 participants | 45 participants | 128 participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 21 Participants | 19 Participants | 16 Participants | 56 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 44 Participants | 44 Participants | 52 Participants | 140 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 23 Participants | 24 Participants | 18 Participants | 65 Participants |
| Race (NIH/OMB) More than one race | 2 Participants | 2 Participants | 4 Participants | 8 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 39 Participants | 36 Participants | 46 Participants | 121 Participants |
| Region of Enrollment United States | 65 participants | 63 participants | 68 participants | 196 participants |
| Sex: Female, Male Female | 35 Participants | 24 Participants | 29 Participants | 88 Participants |
| Sex: Female, Male Male | 30 Participants | 39 Participants | 39 Participants | 108 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 28 / 68 | 31 / 65 | 27 / 63 |
| serious Total, serious adverse events | 0 / 68 | 1 / 65 | 3 / 63 |
Outcome results
Primary
Change From Baseline to Visit 4 in the Mean Daily Composite Score Based on the Pediatric Asthma Caregiver Assessments (PACA)
The daily composite score is the sum of the scores of 5 domains: Nocturnal Awakenings Due to Wheeze and Cough, Daytime Wheeze, Daytime Cough, Shortness of Breath, and Asthma Symptom Score. A possible score of 0 (no symptoms) to 19 (severe symptoms). The mean daily composite score at Visit 4 is defined as the mean of the daily composite scores in the week prior to Visit 4.
Time frame: Baseline, Visit 4 (Week 4)
Population: Intent-to-Treat Population. Only those subjects who had non-missing data at Week 4 and at Baseline were included. Subjects who discontinued from the study prior to Week 4 are not included in this analysis
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline to Visit 4 in the Mean Daily Composite Score Based on the Pediatric Asthma Caregiver Assessments (PACA) | -1.21 units on a scale | Standard Deviation 2.722 |
| Levalbuterol MDI | Change From Baseline to Visit 4 in the Mean Daily Composite Score Based on the Pediatric Asthma Caregiver Assessments (PACA) | -0.67 units on a scale | Standard Deviation 2.092 |
| Levalbuterol UDV | Change From Baseline to Visit 4 in the Mean Daily Composite Score Based on the Pediatric Asthma Caregiver Assessments (PACA) | -0.52 units on a scale | Standard Deviation 2.843 |
Comparison: 195 subjects were randomized in order to achieve 150 subjects completing the study. The sample size was set based on FDA requirements, and was outside of statistical considerations.95% CI: [-1.412, 0.342]
Comparison: 195 subjects were randomized in order to achieve 150 subjects completing the study. The sample size was set based on FDA requirements, and was outside of statistical considerations95% CI: [-1.714, 0.335]
Comparison: 195 subjects were randomized in order to achieve 150 subjects completing the study. The sample size was set based on FDA requirements, and was outside of statistical considerations.95% CI: [-1.08, 0.771]
Secondary
Caregiver Global Assessment - Question 1
Since the start of the study, how would you evaluate your child's asthma symptoms?
Time frame: Visit 4 (End of 28 day treatment period)
Population: Intent-to-Treat Population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Caregiver Global Assessment - Question 1 | Moderately Better | 16 Number of subjects |
| Placebo | Caregiver Global Assessment - Question 1 | Slightly Worse | 1 Number of subjects |
| Placebo | Caregiver Global Assessment - Question 1 | The Same | 12 Number of subjects |
| Placebo | Caregiver Global Assessment - Question 1 | Much Better | 21 Number of subjects |
| Placebo | Caregiver Global Assessment - Question 1 | Much Worse | 0 Number of subjects |
| Placebo | Caregiver Global Assessment - Question 1 | Moderately Worse | 0 Number of subjects |
| Placebo | Caregiver Global Assessment - Question 1 | Slightly Better | 12 Number of subjects |
| Levalbuterol MDI | Caregiver Global Assessment - Question 1 | The Same | 11 Number of subjects |
| Levalbuterol MDI | Caregiver Global Assessment - Question 1 | Much Better | 21 Number of subjects |
| Levalbuterol MDI | Caregiver Global Assessment - Question 1 | Moderately Better | 14 Number of subjects |
| Levalbuterol MDI | Caregiver Global Assessment - Question 1 | Slightly Better | 12 Number of subjects |
| Levalbuterol MDI | Caregiver Global Assessment - Question 1 | Slightly Worse | 2 Number of subjects |
| Levalbuterol MDI | Caregiver Global Assessment - Question 1 | Moderately Worse | 0 Number of subjects |
| Levalbuterol MDI | Caregiver Global Assessment - Question 1 | Much Worse | 0 Number of subjects |
| Levalbuterol UDV | Caregiver Global Assessment - Question 1 | Slightly Worse | 0 Number of subjects |
| Levalbuterol UDV | Caregiver Global Assessment - Question 1 | Moderately Better | 13 Number of subjects |
| Levalbuterol UDV | Caregiver Global Assessment - Question 1 | Much Worse | 0 Number of subjects |
| Levalbuterol UDV | Caregiver Global Assessment - Question 1 | Moderately Worse | 1 Number of subjects |
| Levalbuterol UDV | Caregiver Global Assessment - Question 1 | The Same | 12 Number of subjects |
| Levalbuterol UDV | Caregiver Global Assessment - Question 1 | Slightly Better | 8 Number of subjects |
| Levalbuterol UDV | Caregiver Global Assessment - Question 1 | Much Better | 21 Number of subjects |
Secondary
Caregiver Global Assessment - Question 2
Since the start of the study, how would you evaluate your ability to manage your child's asthma?
Time frame: Visit 4 (End of 28 day treatment period)
Population: Intent-to-Treat Population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Caregiver Global Assessment - Question 2 | Moderately Better | 12 Number of subjects |
| Placebo | Caregiver Global Assessment - Question 2 | Moderately Worse | 0 Number of subjects |
| Placebo | Caregiver Global Assessment - Question 2 | Much Worse | 0 Number of subjects |
| Placebo | Caregiver Global Assessment - Question 2 | Slightly Better | 11 Number of subjects |
| Placebo | Caregiver Global Assessment - Question 2 | Much Better | 27 Number of subjects |
| Placebo | Caregiver Global Assessment - Question 2 | The Same | 11 Number of subjects |
| Placebo | Caregiver Global Assessment - Question 2 | Slightly Worse | 1 Number of subjects |
| Levalbuterol MDI | Caregiver Global Assessment - Question 2 | Slightly Worse | 0 Number of subjects |
| Levalbuterol MDI | Caregiver Global Assessment - Question 2 | Slightly Better | 10 Number of subjects |
| Levalbuterol MDI | Caregiver Global Assessment - Question 2 | Moderately Worse | 0 Number of subjects |
| Levalbuterol MDI | Caregiver Global Assessment - Question 2 | Moderately Better | 6 Number of subjects |
| Levalbuterol MDI | Caregiver Global Assessment - Question 2 | The Same | 12 Number of subjects |
| Levalbuterol MDI | Caregiver Global Assessment - Question 2 | Much Worse | 0 Number of subjects |
| Levalbuterol MDI | Caregiver Global Assessment - Question 2 | Much Better | 32 Number of subjects |
| Levalbuterol UDV | Caregiver Global Assessment - Question 2 | Much Worse | 0 Number of subjects |
| Levalbuterol UDV | Caregiver Global Assessment - Question 2 | Much Better | 29 Number of subjects |
| Levalbuterol UDV | Caregiver Global Assessment - Question 2 | Moderately Better | 10 Number of subjects |
| Levalbuterol UDV | Caregiver Global Assessment - Question 2 | Slightly Better | 4 Number of subjects |
| Levalbuterol UDV | Caregiver Global Assessment - Question 2 | Slightly Worse | 0 Number of subjects |
| Levalbuterol UDV | Caregiver Global Assessment - Question 2 | Moderately Worse | 0 Number of subjects |
| Levalbuterol UDV | Caregiver Global Assessment - Question 2 | The Same | 12 Number of subjects |
Secondary
Caregiver Global Assessment - Question 3
Overall I was: Very satisfied with the control of the child's asthma symptoms while enrolled in this study, Moderately satisfied with the control of the child's asthma symptoms while enrolled in this study, Slightly satisfied with the control of the child's asthma symptoms while enrolled in this study, Not satisfied with the control of the child's asthma symptoms while enrolled in this study or answer Missing
Time frame: Visit 4 (End of 28 day treatment period)
Population: Intent-to-Treat Population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Caregiver Global Assessment - Question 3 | Very satisfied | 47 Number of subjects |
| Placebo | Caregiver Global Assessment - Question 3 | Moderately satisfied | 11 Number of subjects |
| Placebo | Caregiver Global Assessment - Question 3 | Slightly satisfied | 4 Number of subjects |
| Placebo | Caregiver Global Assessment - Question 3 | Not satisfied | 0 Number of subjects |
| Levalbuterol MDI | Caregiver Global Assessment - Question 3 | Not satisfied | 1 Number of subjects |
| Levalbuterol MDI | Caregiver Global Assessment - Question 3 | Very satisfied | 45 Number of subjects |
| Levalbuterol MDI | Caregiver Global Assessment - Question 3 | Slightly satisfied | 2 Number of subjects |
| Levalbuterol MDI | Caregiver Global Assessment - Question 3 | Moderately satisfied | 12 Number of subjects |
| Levalbuterol UDV | Caregiver Global Assessment - Question 3 | Not satisfied | 2 Number of subjects |
| Levalbuterol UDV | Caregiver Global Assessment - Question 3 | Moderately satisfied | 7 Number of subjects |
| Levalbuterol UDV | Caregiver Global Assessment - Question 3 | Slightly satisfied | 1 Number of subjects |
| Levalbuterol UDV | Caregiver Global Assessment - Question 3 | Very satisfied | 45 Number of subjects |
Secondary
Change From Baseline in In-Clinic Peak Expiratory Flow to Postdose Timepoint at Visit 3
Time frame: Baseline, Visit 3, pre-dose (approximately 14 days after randomization)
Population: Intent-to-Treat Population - PEF Cohort (Subjects able to perform PEFs)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in In-Clinic Peak Expiratory Flow to Postdose Timepoint at Visit 3 | -0.23 liters | Standard Deviation 0.255 |
| Levalbuterol MDI | Change From Baseline in In-Clinic Peak Expiratory Flow to Postdose Timepoint at Visit 3 | 0.14 liters | Standard Deviation 0.251 |
| Levalbuterol UDV | Change From Baseline in In-Clinic Peak Expiratory Flow to Postdose Timepoint at Visit 3 | 0.03 liters | Standard Deviation 0.12 |
Secondary
Change From Baseline in In-Clinic Peak Expiratory Flow to Postdose Timepoint at Visit 4
Time frame: Visit 4: pre-dose (approximately 28 days after randomization) , 30 minutes post-dose, 1 hour post-dose, 4 hours post-dose, 6 hours post-dose
Population: Intent-to-Treat Population - PEF Cohort (Subjects able to perform PEFs)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in In-Clinic Peak Expiratory Flow to Postdose Timepoint at Visit 4 | Visit 4, 4 hours post-dose | -0.11 liters | Standard Deviation 0.382 |
| Placebo | Change From Baseline in In-Clinic Peak Expiratory Flow to Postdose Timepoint at Visit 4 | Visit 4, 1 hour post-dose | -0.03 liters | Standard Deviation 0.332 |
| Placebo | Change From Baseline in In-Clinic Peak Expiratory Flow to Postdose Timepoint at Visit 4 | Visit 4, pre-dose | -0.25 liters | Standard Deviation 0.307 |
| Placebo | Change From Baseline in In-Clinic Peak Expiratory Flow to Postdose Timepoint at Visit 4 | Visit 4, 30 minutes post-dose | -0.17 liters | Standard Deviation 0.323 |
| Placebo | Change From Baseline in In-Clinic Peak Expiratory Flow to Postdose Timepoint at Visit 4 | Visit 4, 6 hours post-dose | -0.07 liters | Standard Deviation 0.26 |
| Levalbuterol MDI | Change From Baseline in In-Clinic Peak Expiratory Flow to Postdose Timepoint at Visit 4 | Visit 4, 1 hour post-dose | 0.40 liters | Standard Deviation 0.242 |
| Levalbuterol MDI | Change From Baseline in In-Clinic Peak Expiratory Flow to Postdose Timepoint at Visit 4 | Visit 4, pre-dose | 0.29 liters | Standard Deviation 0.313 |
| Levalbuterol MDI | Change From Baseline in In-Clinic Peak Expiratory Flow to Postdose Timepoint at Visit 4 | Visit 4, 30 minutes post-dose | 0.29 liters | Standard Deviation 0.247 |
| Levalbuterol MDI | Change From Baseline in In-Clinic Peak Expiratory Flow to Postdose Timepoint at Visit 4 | Visit 4, 4 hours post-dose | 0.30 liters | Standard Deviation 0.305 |
| Levalbuterol MDI | Change From Baseline in In-Clinic Peak Expiratory Flow to Postdose Timepoint at Visit 4 | Visit 4, 6 hours post-dose | 0.20 liters | Standard Deviation 0.173 |
| Levalbuterol UDV | Change From Baseline in In-Clinic Peak Expiratory Flow to Postdose Timepoint at Visit 4 | Visit 4, 6 hours post-dose | 0.09 liters | Standard Deviation 0.361 |
| Levalbuterol UDV | Change From Baseline in In-Clinic Peak Expiratory Flow to Postdose Timepoint at Visit 4 | Visit 4, 4 hours post-dose | 0.11 liters | Standard Deviation 0.181 |
| Levalbuterol UDV | Change From Baseline in In-Clinic Peak Expiratory Flow to Postdose Timepoint at Visit 4 | Visit 4, pre-dose | 0.04 liters | Standard Deviation 0.146 |
| Levalbuterol UDV | Change From Baseline in In-Clinic Peak Expiratory Flow to Postdose Timepoint at Visit 4 | Visit 4, 1 hour post-dose | 0.16 liters | Standard Deviation 0.227 |
| Levalbuterol UDV | Change From Baseline in In-Clinic Peak Expiratory Flow to Postdose Timepoint at Visit 4 | Visit 4, 30 minutes post-dose | 0.42 liters | Standard Deviation 0.585 |
Secondary
Change From Baseline in In-Clinic Peak Expiratory Flow to Postdose Timepoints at Visit 2
Peak expiratory flow (PEF) measures how fast a person can breathe out using the greatest effort
Time frame: Baseline, Visit 2: 30 minutes post-dose (on the day of randomization), 1 hour post-dose, 4 hours post-dose, 6 hours post-dose
Population: Intent-to-Treat Population - PEF Cohort (Subjects able to perform PEFs)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in In-Clinic Peak Expiratory Flow to Postdose Timepoints at Visit 2 | Visit 2, 30 minutes post-dose | -0.08 liters | Standard Deviation 0.147 |
| Placebo | Change From Baseline in In-Clinic Peak Expiratory Flow to Postdose Timepoints at Visit 2 | Visit 2, 1 hour post-dose | -0.04 liters | Standard Deviation 0.183 |
| Placebo | Change From Baseline in In-Clinic Peak Expiratory Flow to Postdose Timepoints at Visit 2 | Visit 2, 4 hours post-dose | -0.09 liters | Standard Deviation 0.303 |
| Placebo | Change From Baseline in In-Clinic Peak Expiratory Flow to Postdose Timepoints at Visit 2 | Visit 2, 6 hours post-dose | -0.07 liters | Standard Deviation 0.121 |
| Levalbuterol MDI | Change From Baseline in In-Clinic Peak Expiratory Flow to Postdose Timepoints at Visit 2 | Visit 2, 6 hours post-dose | 0.12 liters | Standard Deviation 0.164 |
| Levalbuterol MDI | Change From Baseline in In-Clinic Peak Expiratory Flow to Postdose Timepoints at Visit 2 | Visit 2, 30 minutes post-dose | 0.17 liters | Standard Deviation 0.211 |
| Levalbuterol MDI | Change From Baseline in In-Clinic Peak Expiratory Flow to Postdose Timepoints at Visit 2 | Visit 2, 4 hours post-dose | 0.06 liters | Standard Deviation 0.098 |
| Levalbuterol MDI | Change From Baseline in In-Clinic Peak Expiratory Flow to Postdose Timepoints at Visit 2 | Visit 2, 1 hour post-dose | 0.13 liters | Standard Deviation 0.162 |
| Levalbuterol UDV | Change From Baseline in In-Clinic Peak Expiratory Flow to Postdose Timepoints at Visit 2 | Visit 2, 6 hours post-dose | 0.06 liters | Standard Deviation 0.213 |
| Levalbuterol UDV | Change From Baseline in In-Clinic Peak Expiratory Flow to Postdose Timepoints at Visit 2 | Visit 2, 1 hour post-dose | 0.18 liters | Standard Deviation 0.176 |
| Levalbuterol UDV | Change From Baseline in In-Clinic Peak Expiratory Flow to Postdose Timepoints at Visit 2 | Visit 2, 4 hours post-dose | 0.04 liters | Standard Deviation 0.188 |
| Levalbuterol UDV | Change From Baseline in In-Clinic Peak Expiratory Flow to Postdose Timepoints at Visit 2 | Visit 2, 30 minutes post-dose | 0.16 liters | Standard Deviation 0.101 |
Secondary
Change From Baseline in the At-Home Mean Daily Peak Expiratory Flow (PEF to Postdose Timepoint at Visit 3 and Visit 4
Mean of the daily pre-dose PEF values in the week prior to visit in those subjects aged 24 to \<48 months capable of performing acceptable and reproducible PEF maneuvers.
Time frame: Baseline, Visit 3 (the week prior to Visit 3) and Visit 4
Population: Intent-to-Treat Population - PEF Cohort (Subjects able to perform PEFs)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in the At-Home Mean Daily Peak Expiratory Flow (PEF to Postdose Timepoint at Visit 3 and Visit 4 | Visit 3 | 0.07 liters | Standard Deviation 0.164 |
| Placebo | Change From Baseline in the At-Home Mean Daily Peak Expiratory Flow (PEF to Postdose Timepoint at Visit 3 and Visit 4 | Visit 4 | 0.00 liters | Standard Deviation 0.205 |
| Levalbuterol MDI | Change From Baseline in the At-Home Mean Daily Peak Expiratory Flow (PEF to Postdose Timepoint at Visit 3 and Visit 4 | Visit 3 | 0.12 liters | Standard Deviation 0.209 |
| Levalbuterol MDI | Change From Baseline in the At-Home Mean Daily Peak Expiratory Flow (PEF to Postdose Timepoint at Visit 3 and Visit 4 | Visit 4 | 0.08 liters | Standard Deviation 0.186 |
| Levalbuterol UDV | Change From Baseline in the At-Home Mean Daily Peak Expiratory Flow (PEF to Postdose Timepoint at Visit 3 and Visit 4 | Visit 3 | 0.01 liters | Standard Deviation 0.193 |
| Levalbuterol UDV | Change From Baseline in the At-Home Mean Daily Peak Expiratory Flow (PEF to Postdose Timepoint at Visit 3 and Visit 4 | Visit 4 | -0.01 liters | Standard Deviation 0.096 |
Secondary
Change From Baseline to Visit 2 to Visit 3 in the Mean Daily Composite Score Based on the Daytime and Nighttime Asthma Symptom Scores as Measured by the Pediatric Asthma Questionnaire
The daily composite score is the sum of the scores of 7 items: Difficulty Breathing, Cough, Wheeze, Activity Limitation, Level of Activity Limitation, Overall Symptom Score, and Nighttime Asthma. The range for the PAQ is 0 (no symptoms) to 27 (severe symptoms). The mean daily composite score from Visit 2 to Visit 3 is defined as the mean of the daily composite scores from Visit 2 (inclusive) to the day prior to Visit 3.
Time frame: The days from Visit 2 (inclusive) to the day prior to Visit 3 - approximately 14 days
Population: Intent-to-Treat Population
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline to Visit 2 to Visit 3 in the Mean Daily Composite Score Based on the Daytime and Nighttime Asthma Symptom Scores as Measured by the Pediatric Asthma Questionnaire | -0.87 units on a scale | Standard Deviation 2.797 |
| Levalbuterol MDI | Change From Baseline to Visit 2 to Visit 3 in the Mean Daily Composite Score Based on the Daytime and Nighttime Asthma Symptom Scores as Measured by the Pediatric Asthma Questionnaire | -0.36 units on a scale | Standard Deviation 2.872 |
| Levalbuterol UDV | Change From Baseline to Visit 2 to Visit 3 in the Mean Daily Composite Score Based on the Daytime and Nighttime Asthma Symptom Scores as Measured by the Pediatric Asthma Questionnaire | -0.08 units on a scale | Standard Deviation 2.589 |
Secondary
Change From Baseline to Visit 2 to Visit 3 in the Mean Daily Composite Score Based on the Pediatric Asthma Caregiver Assessment
The daily composite score is the sum of the scores of 5 domains: Nocturnal Awakenings Due to Wheeze and Cough, Daytime Wheeze, Daytime Cough, Shortness of Breath, and Asthma Symptom Score. A possible score of 0 (no symptoms) to 19 (severe symptoms). The mean daily composite score from Visit 2 to Visit 3 is defined as the mean of the daily composite scores from Visit 2 (inclusive) to the day prior to Visit 3.
Time frame: The days from Visit 2 (inclusive) to the day prior to Visit 3 - approximately 14 days
Population: Intent-to-Treat Population
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline to Visit 2 to Visit 3 in the Mean Daily Composite Score Based on the Pediatric Asthma Caregiver Assessment | -0.82 units on a scale | Standard Deviation 2.417 |
| Levalbuterol MDI | Change From Baseline to Visit 2 to Visit 3 in the Mean Daily Composite Score Based on the Pediatric Asthma Caregiver Assessment | -0.25 units on a scale | Standard Deviation 2.041 |
| Levalbuterol UDV | Change From Baseline to Visit 2 to Visit 3 in the Mean Daily Composite Score Based on the Pediatric Asthma Caregiver Assessment | -0.15 units on a scale | Standard Deviation 2.067 |
Secondary
Change From Baseline to Visit 3 and Visit 4 in the Pediatric Asthma Caregiver's Quality of Life Questionnaire (PACQLA) Composite Score
The PACQLQ composite score was calculated as the mean of the scores of the 13 individual questions. Composite scores could range from 1 to 7. Lower scores indicated greater impact of disease on quality of life.
Time frame: Visit 3 and Visit 4 (End of 28 day treatment period)
Population: Intent-to-Treat Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline to Visit 3 and Visit 4 in the Pediatric Asthma Caregiver's Quality of Life Questionnaire (PACQLA) Composite Score | Visit 4 | 0.41 Units on a scale | Standard Deviation 0.931 |
| Placebo | Change From Baseline to Visit 3 and Visit 4 in the Pediatric Asthma Caregiver's Quality of Life Questionnaire (PACQLA) Composite Score | Visit 3 | 0.34 Units on a scale | Standard Deviation 0.888 |
| Levalbuterol MDI | Change From Baseline to Visit 3 and Visit 4 in the Pediatric Asthma Caregiver's Quality of Life Questionnaire (PACQLA) Composite Score | Visit 3 | 0.35 Units on a scale | Standard Deviation 0.976 |
| Levalbuterol MDI | Change From Baseline to Visit 3 and Visit 4 in the Pediatric Asthma Caregiver's Quality of Life Questionnaire (PACQLA) Composite Score | Visit 4 | 0.44 Units on a scale | Standard Deviation 1.171 |
| Levalbuterol UDV | Change From Baseline to Visit 3 and Visit 4 in the Pediatric Asthma Caregiver's Quality of Life Questionnaire (PACQLA) Composite Score | Visit 3 | 0.18 Units on a scale | Standard Deviation 0.944 |
| Levalbuterol UDV | Change From Baseline to Visit 3 and Visit 4 in the Pediatric Asthma Caregiver's Quality of Life Questionnaire (PACQLA) Composite Score | Visit 4 | 0.21 Units on a scale | Standard Deviation 0.883 |
Secondary
Change From Baseline to Visit 3 in Mean Daily Composite Score Based on the Pediatric Asthma Caregiver Assessment
The daily composite score is the sum of the scores of 5 domains: Nocturnal Awakenings Due to Wheeze and Cough, Daytime Wheeze, Daytime Cough, Shortness of Breath, and Asthma Symptom Score. A possible score of 0 (no symptoms) to 19 (severe symptoms). The mean daily composite score at Visit 3 is defined as the mean of the daily composite scores in the 7 days prior to Visit 3.
Time frame: Baseline, Visit 3 (Week 3)
Population: Intent-to-Treat Population
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline to Visit 3 in Mean Daily Composite Score Based on the Pediatric Asthma Caregiver Assessment | -0.83 units on a scale | Standard Deviation 2.913 |
| Levalbuterol MDI | Change From Baseline to Visit 3 in Mean Daily Composite Score Based on the Pediatric Asthma Caregiver Assessment | -0.28 units on a scale | Standard Deviation 2.49 |
| Levalbuterol UDV | Change From Baseline to Visit 3 in Mean Daily Composite Score Based on the Pediatric Asthma Caregiver Assessment | -0.22 units on a scale | Standard Deviation 2.545 |
Secondary
Change From Baseline to Visit 3 in the Mean Daily Composite Score Based on the Daytime and Nighttime Asthma Symptom Scores as Measured by the Pediatric Asthma Questionnaire (PAQ)
The daily composite score is the sum of the scores of 7 items: Difficulty Breathing, Cough, Wheeze, Activity Limitation, Level of Activity Limitation, Overall Symptom Score, and Nighttime Asthma. The range for the PAQ is 0 (no symptoms) to 27 (severe symptoms). The mean daily composite score at Visit 3 is defined as the mean daily composite scores for 7 days prior to Visit 3.
Time frame: Baseline, Visit 3 (Week 3)
Population: Intent-to-Treat Population
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline to Visit 3 in the Mean Daily Composite Score Based on the Daytime and Nighttime Asthma Symptom Scores as Measured by the Pediatric Asthma Questionnaire (PAQ) | -0.82 units on a scale | Standard Deviation 3.457 |
| Levalbuterol MDI | Change From Baseline to Visit 3 in the Mean Daily Composite Score Based on the Daytime and Nighttime Asthma Symptom Scores as Measured by the Pediatric Asthma Questionnaire (PAQ) | -0.45 units on a scale | Standard Deviation 3.522 |
| Levalbuterol UDV | Change From Baseline to Visit 3 in the Mean Daily Composite Score Based on the Daytime and Nighttime Asthma Symptom Scores as Measured by the Pediatric Asthma Questionnaire (PAQ) | 0.00 units on a scale | Standard Deviation 3.199 |
Secondary
Change From Baseline to Visit 3 to Visit 4 in the Mean Daily Composite Score Based on the Daytime and Nighttime Asthma Symptom Score as Measured by the Pediatric Asthma Questionnaire
The daily composite score is the sum of the scores of 7 items: Difficulty Breathing, Cough, Wheeze, Activity Limitation, Level of Activity Limitation, Overall Symptom Score, and Nighttime Asthma. The range for the PAQ is 0 (no symptoms) to 27 (severe symptoms). The mean daily composite score from Visit 3 to Visit 4 is defined as the mean of the daily composite scores from Visit 3 (inclusive) to the day prior to Visit 4.
Time frame: The days from Visit 3 (inclusive) to the day prior to Visit 4 - approximately 14 days
Population: Intent-to-Treat Population
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline to Visit 3 to Visit 4 in the Mean Daily Composite Score Based on the Daytime and Nighttime Asthma Symptom Score as Measured by the Pediatric Asthma Questionnaire | -1.24 units on a scale | Standard Deviation 2.979 |
| Levalbuterol MDI | Change From Baseline to Visit 3 to Visit 4 in the Mean Daily Composite Score Based on the Daytime and Nighttime Asthma Symptom Score as Measured by the Pediatric Asthma Questionnaire | -0.61 units on a scale | Standard Deviation 2.706 |
| Levalbuterol UDV | Change From Baseline to Visit 3 to Visit 4 in the Mean Daily Composite Score Based on the Daytime and Nighttime Asthma Symptom Score as Measured by the Pediatric Asthma Questionnaire | -0.37 units on a scale | Standard Deviation 2.572 |
Secondary
Change From Baseline to Visit 3 to Visit 4 in the Mean Daily Composite Score Based on the Pediatric Asthma Caregiver Assessment
The daily composite score is the sum of the scores of 5 domains: Nocturnal Awakenings Due to Wheeze and Cough, Daytime Wheeze, Daytime Cough, Shortness of Breath, and Asthma Symptom Score. A possible score of 0 (no symptoms) to 19 (severe symptoms). The mean daily composite score from Visit 3 to Visit 4 is defined as the mean of the daily composite scores from Visit 3 (inclusive) to the day prior to Visit 4.
Time frame: The days from Visit 3 (inclusive) to the day prior to Visit 4 - approximately 14 days
Population: Intent-to-Treat Population
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline to Visit 3 to Visit 4 in the Mean Daily Composite Score Based on the Pediatric Asthma Caregiver Assessment | -1.08 units on a scale | Standard Deviation 2.478 |
| Levalbuterol MDI | Change From Baseline to Visit 3 to Visit 4 in the Mean Daily Composite Score Based on the Pediatric Asthma Caregiver Assessment | -0.40 units on a scale | Standard Deviation 2.285 |
| Levalbuterol UDV | Change From Baseline to Visit 3 to Visit 4 in the Mean Daily Composite Score Based on the Pediatric Asthma Caregiver Assessment | -0.52 units on a scale | Standard Deviation 2.331 |
Secondary
Change From Baseline to Visit 4 in the Mean Daily Composite Score Based on the Daytime and Nighttime Asthma Symptom Scores as Measured by Pediatric Asthma Questionnaire
The daily composite score is the sum of the scores of 7 items: Difficulty Breathing, Cough, Wheeze, Activity Limitation, Level of Activity Limitation, Overall Symptom Score, and Nighttime Asthma. The range for the PAQ is 0 (no symptoms) to 27 (severe symptoms). The mean daily composite score at Visit 4 is defined as the mean daily composite scores in the 7 days prior to Visit 4.
Time frame: Baseline, Visit 4 (Week 4)
Population: Intent-to-Treat Population
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline to Visit 4 in the Mean Daily Composite Score Based on the Daytime and Nighttime Asthma Symptom Scores as Measured by Pediatric Asthma Questionnaire | -1.39 units on a scale | Standard Deviation 3.213 |
| Levalbuterol MDI | Change From Baseline to Visit 4 in the Mean Daily Composite Score Based on the Daytime and Nighttime Asthma Symptom Scores as Measured by Pediatric Asthma Questionnaire | -0.91 units on a scale | Standard Deviation 2.585 |
| Levalbuterol UDV | Change From Baseline to Visit 4 in the Mean Daily Composite Score Based on the Daytime and Nighttime Asthma Symptom Scores as Measured by Pediatric Asthma Questionnaire | -0.47 units on a scale | Standard Deviation 2.931 |
Secondary
Investigator Global Assessment - Question 1
Since the start of the study, how would you evaluate the child's asthma symptoms?
Time frame: Visit 4 (End of 28 day treatment period)
Population: Intent-to-Treat Population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Investigator Global Assessment - Question 1 | Moderately Better | 23 Number of subjects |
| Placebo | Investigator Global Assessment - Question 1 | Slightly Worse | 0 Number of subjects |
| Placebo | Investigator Global Assessment - Question 1 | The Same | 14 Number of subjects |
| Placebo | Investigator Global Assessment - Question 1 | Much Better | 12 Number of subjects |
| Placebo | Investigator Global Assessment - Question 1 | Much Worse | 0 Number of subjects |
| Placebo | Investigator Global Assessment - Question 1 | Moderately Worse | 1 Number of subjects |
| Placebo | Investigator Global Assessment - Question 1 | Slightly Better | 12 Number of subjects |
| Levalbuterol MDI | Investigator Global Assessment - Question 1 | The Same | 12 Number of subjects |
| Levalbuterol MDI | Investigator Global Assessment - Question 1 | Much Better | 17 Number of subjects |
| Levalbuterol MDI | Investigator Global Assessment - Question 1 | Moderately Better | 15 Number of subjects |
| Levalbuterol MDI | Investigator Global Assessment - Question 1 | Slightly Better | 14 Number of subjects |
| Levalbuterol MDI | Investigator Global Assessment - Question 1 | Slightly Worse | 1 Number of subjects |
| Levalbuterol MDI | Investigator Global Assessment - Question 1 | Moderately Worse | 1 Number of subjects |
| Levalbuterol MDI | Investigator Global Assessment - Question 1 | Much Worse | 0 Number of subjects |
| Levalbuterol UDV | Investigator Global Assessment - Question 1 | Slightly Worse | 1 Number of subjects |
| Levalbuterol UDV | Investigator Global Assessment - Question 1 | Moderately Better | 13 Number of subjects |
| Levalbuterol UDV | Investigator Global Assessment - Question 1 | Much Worse | 0 Number of subjects |
| Levalbuterol UDV | Investigator Global Assessment - Question 1 | Moderately Worse | 1 Number of subjects |
| Levalbuterol UDV | Investigator Global Assessment - Question 1 | The Same | 13 Number of subjects |
| Levalbuterol UDV | Investigator Global Assessment - Question 1 | Slightly Better | 11 Number of subjects |
| Levalbuterol UDV | Investigator Global Assessment - Question 1 | Much Better | 16 Number of subjects |
Secondary
Investigator Global Assessment - Question 2
Since the start of the study, how would you evaluate your ability to manage the subject's asthma?
Time frame: Visit 4 (End of 28 day treatment period)
Population: Intent-to-Treat Population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Investigator Global Assessment - Question 2 | Much Better | 19 Number of subjects |
| Placebo | Investigator Global Assessment - Question 2 | Moderately Better | 17 Number of subjects |
| Placebo | Investigator Global Assessment - Question 2 | Slightly Worse | 0 Number of subjects |
| Placebo | Investigator Global Assessment - Question 2 | Slightly Better | 8 Number of subjects |
| Placebo | Investigator Global Assessment - Question 2 | The Same | 17 Number of subjects |
| Placebo | Investigator Global Assessment - Question 2 | Moderately Worse | 1 Number of subjects |
| Placebo | Investigator Global Assessment - Question 2 | Much Worse | 0 Number of subjects |
| Levalbuterol MDI | Investigator Global Assessment - Question 2 | The Same | 15 Number of subjects |
| Levalbuterol MDI | Investigator Global Assessment - Question 2 | Much Better | 21 Number of subjects |
| Levalbuterol MDI | Investigator Global Assessment - Question 2 | Slightly Better | 12 Number of subjects |
| Levalbuterol MDI | Investigator Global Assessment - Question 2 | Much Worse | 0 Number of subjects |
| Levalbuterol MDI | Investigator Global Assessment - Question 2 | Moderately Better | 12 Number of subjects |
| Levalbuterol MDI | Investigator Global Assessment - Question 2 | Moderately Worse | 0 Number of subjects |
| Levalbuterol MDI | Investigator Global Assessment - Question 2 | Slightly Worse | 0 Number of subjects |
| Levalbuterol UDV | Investigator Global Assessment - Question 2 | Moderately Better | 11 Number of subjects |
| Levalbuterol UDV | Investigator Global Assessment - Question 2 | Slightly Better | 7 Number of subjects |
| Levalbuterol UDV | Investigator Global Assessment - Question 2 | Much Worse | 0 Number of subjects |
| Levalbuterol UDV | Investigator Global Assessment - Question 2 | The Same | 14 Number of subjects |
| Levalbuterol UDV | Investigator Global Assessment - Question 2 | Slightly Worse | 0 Number of subjects |
| Levalbuterol UDV | Investigator Global Assessment - Question 2 | Much Better | 23 Number of subjects |
| Levalbuterol UDV | Investigator Global Assessment - Question 2 | Moderately Worse | 0 Number of subjects |
Secondary
Percent Change From Baseline in In-Clinic Peak Expiratory Flow to Postdose Timepoints at Visit 2
Time frame: Baseline, Visit 2: , 30 minutes post-dose (on the day of randomization), 1 hour post-dose, 4 hours post-dose, 6 hours post-dose
Population: Intent-to-Treat Population - PEF Cohort (Subjects able to perform PEFs)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Percent Change From Baseline in In-Clinic Peak Expiratory Flow to Postdose Timepoints at Visit 2 | Visit 2, 30 minutes post-does | -5.42 percent change | Standard Deviation 9.94 |
| Placebo | Percent Change From Baseline in In-Clinic Peak Expiratory Flow to Postdose Timepoints at Visit 2 | Visit 2, 1 hour post-dose | -2.83 percent change | Standard Deviation 15.094 |
| Placebo | Percent Change From Baseline in In-Clinic Peak Expiratory Flow to Postdose Timepoints at Visit 2 | Visit 2, 4 hours post-dose | -4.22 percent change | Standard Deviation 17.886 |
| Placebo | Percent Change From Baseline in In-Clinic Peak Expiratory Flow to Postdose Timepoints at Visit 2 | Visit 2, 6 hours post-dose | -5.24 percent change | Standard Deviation 10.44 |
| Levalbuterol MDI | Percent Change From Baseline in In-Clinic Peak Expiratory Flow to Postdose Timepoints at Visit 2 | Visit 2, 6 hours post-dose | 17.21 percent change | Standard Deviation 24.013 |
| Levalbuterol MDI | Percent Change From Baseline in In-Clinic Peak Expiratory Flow to Postdose Timepoints at Visit 2 | Visit 2, 30 minutes post-does | 23.22 percent change | Standard Deviation 36.195 |
| Levalbuterol MDI | Percent Change From Baseline in In-Clinic Peak Expiratory Flow to Postdose Timepoints at Visit 2 | Visit 2, 4 hours post-dose | 9.54 percent change | Standard Deviation 15.467 |
| Levalbuterol MDI | Percent Change From Baseline in In-Clinic Peak Expiratory Flow to Postdose Timepoints at Visit 2 | Visit 2, 1 hour post-dose | 18.21 percent change | Standard Deviation 26.225 |
| Levalbuterol UDV | Percent Change From Baseline in In-Clinic Peak Expiratory Flow to Postdose Timepoints at Visit 2 | Visit 2, 6 hours post-dose | 14.40 percent change | Standard Deviation 41.548 |
| Levalbuterol UDV | Percent Change From Baseline in In-Clinic Peak Expiratory Flow to Postdose Timepoints at Visit 2 | Visit 2, 1 hour post-dose | 25.05 percent change | Standard Deviation 37.207 |
| Levalbuterol UDV | Percent Change From Baseline in In-Clinic Peak Expiratory Flow to Postdose Timepoints at Visit 2 | Visit 2, 4 hours post-dose | 11.74 percent change | Standard Deviation 37.114 |
| Levalbuterol UDV | Percent Change From Baseline in In-Clinic Peak Expiratory Flow to Postdose Timepoints at Visit 2 | Visit 2, 30 minutes post-does | 21.71 percent change | Standard Deviation 23.782 |
Secondary
Percent Change From Baseline in In-Clinic Peak Expiratory Flow to Postdose Timepoints at Visit 3
Time frame: Baseline, Visit 3, pre -dose (approximately 14 days after randomization)
Population: Intent-to-Treat Population - PEF Cohort (Subjects able to perform PEFs)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Percent Change From Baseline in In-Clinic Peak Expiratory Flow to Postdose Timepoints at Visit 3 | -18.58 percent change | Standard Deviation 21.742 |
| Levalbuterol MDI | Percent Change From Baseline in In-Clinic Peak Expiratory Flow to Postdose Timepoints at Visit 3 | 25.36 percent change | Standard Deviation 30.129 |
| Levalbuterol UDV | Percent Change From Baseline in In-Clinic Peak Expiratory Flow to Postdose Timepoints at Visit 3 | 6.02 percent change | Standard Deviation 13.444 |
Secondary
Percent Change From Baseline in In-Clinic Peak Expiratory Flow to Postdose Timepoints at Visit 4
Time frame: Baseline, Visit 4, pre -dose (approximately 28 days after randomization)
Population: Intent-to-Treat Population - PEF Cohort (Subjects able to perform PEFs)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Percent Change From Baseline in In-Clinic Peak Expiratory Flow to Postdose Timepoints at Visit 4 | Visit 4, 4 hours post-dose | -4.67 percent change | Standard Deviation 27.435 |
| Placebo | Percent Change From Baseline in In-Clinic Peak Expiratory Flow to Postdose Timepoints at Visit 4 | Visit 4, 6 hours post-dose | -2.06 percent change | Standard Deviation 21.507 |
| Placebo | Percent Change From Baseline in In-Clinic Peak Expiratory Flow to Postdose Timepoints at Visit 4 | Visit 4, 30 minutes post-dose | -11.69 percent change | Standard Deviation 27.617 |
| Placebo | Percent Change From Baseline in In-Clinic Peak Expiratory Flow to Postdose Timepoints at Visit 4 | Visit 4, 1 hour post-dose | 0.94 percent change | Standard Deviation 24.02 |
| Placebo | Percent Change From Baseline in In-Clinic Peak Expiratory Flow to Postdose Timepoints at Visit 4 | Visit 4, pre-dose | -17.26 percent change | Standard Deviation 23.343 |
| Levalbuterol MDI | Percent Change From Baseline in In-Clinic Peak Expiratory Flow to Postdose Timepoints at Visit 4 | Visit 4, 30 minutes post-dose | 48.94 percent change | Standard Deviation 48.881 |
| Levalbuterol MDI | Percent Change From Baseline in In-Clinic Peak Expiratory Flow to Postdose Timepoints at Visit 4 | Visit 4, 4 hours post-dose | 47.59 percent change | Standard Deviation 42.339 |
| Levalbuterol MDI | Percent Change From Baseline in In-Clinic Peak Expiratory Flow to Postdose Timepoints at Visit 4 | Visit 4, pre-dose | 49.92 percent change | Standard Deviation 48.545 |
| Levalbuterol MDI | Percent Change From Baseline in In-Clinic Peak Expiratory Flow to Postdose Timepoints at Visit 4 | Visit 4, 6 hours post-dose | 32.00 percent change | Standard Deviation 27.657 |
| Levalbuterol MDI | Percent Change From Baseline in In-Clinic Peak Expiratory Flow to Postdose Timepoints at Visit 4 | Visit 4, 1 hour post-dose | 63.76 percent change | Standard Deviation 45.62 |
| Levalbuterol UDV | Percent Change From Baseline in In-Clinic Peak Expiratory Flow to Postdose Timepoints at Visit 4 | Visit 4, 6 hours post-dose | 25.09 percent change | Standard Deviation 69.44 |
| Levalbuterol UDV | Percent Change From Baseline in In-Clinic Peak Expiratory Flow to Postdose Timepoints at Visit 4 | Visit 4, pre-dose | 7.03 percent change | Standard Deviation 18.829 |
| Levalbuterol UDV | Percent Change From Baseline in In-Clinic Peak Expiratory Flow to Postdose Timepoints at Visit 4 | Visit 4, 30 minutes post-dose | 47.47 percent change | Standard Deviation 55.01 |
| Levalbuterol UDV | Percent Change From Baseline in In-Clinic Peak Expiratory Flow to Postdose Timepoints at Visit 4 | Visit 4, 1 hour post-dose | 25.32 percent change | Standard Deviation 47.769 |
| Levalbuterol UDV | Percent Change From Baseline in In-Clinic Peak Expiratory Flow to Postdose Timepoints at Visit 4 | Visit 4, 4 hours post-dose | 20.20 percent change | Standard Deviation 37.895 |
Secondary
Percent Change From Baseline in the At-Home Mean Daily Peak Expiratory Flow (PEF to Postdose Timepoint at Visit 3 and Visit 4)
Mean of the daily pre-dose PEF values in the week prior to visit in those subjects aged 24 to \<48 months capable of performing acceptable and reproducible PEF maneuvers.
Time frame: Visit 3 (the week prior to Visit 3), Visit 4 (the week prior to Visit 4)
Population: Intent-to-Treat Population - PEF Cohort (Subjects able to perform PEFs)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Percent Change From Baseline in the At-Home Mean Daily Peak Expiratory Flow (PEF to Postdose Timepoint at Visit 3 and Visit 4) | Visit 3 | 7.39 percent change | Standard Deviation 16.585 |
| Placebo | Percent Change From Baseline in the At-Home Mean Daily Peak Expiratory Flow (PEF to Postdose Timepoint at Visit 3 and Visit 4) | Visit 4 | 0.21 percent change | Standard Deviation 22.426 |
| Levalbuterol MDI | Percent Change From Baseline in the At-Home Mean Daily Peak Expiratory Flow (PEF to Postdose Timepoint at Visit 3 and Visit 4) | Visit 3 | 15.05 percent change | Standard Deviation 26.849 |
| Levalbuterol MDI | Percent Change From Baseline in the At-Home Mean Daily Peak Expiratory Flow (PEF to Postdose Timepoint at Visit 3 and Visit 4) | Visit 4 | 10.33 percent change | Standard Deviation 24.436 |
| Levalbuterol UDV | Percent Change From Baseline in the At-Home Mean Daily Peak Expiratory Flow (PEF to Postdose Timepoint at Visit 3 and Visit 4) | Visit 3 | 5.30 percent change | Standard Deviation 21.093 |
| Levalbuterol UDV | Percent Change From Baseline in the At-Home Mean Daily Peak Expiratory Flow (PEF to Postdose Timepoint at Visit 3 and Visit 4) | Visit 4 | -1.05 percent change | Standard Deviation 12.155 |
Secondary
Rescue Medication Use - Change From Baseline in Mean Number of Days Used Per Week When Used
Time frame: Visit 2 to Visit 3 (the first 2 weeks of the study) , Visit 3 to Visit 4 (the second 2 weeks of the study), Visit 2 to Visit 4 (the entire 4 weeks of the study)
Population: Intent-to-Treat Population - Subjects who used rescue medication at any time during the first two weeks of the study and who used rescue medication at any time during baseline
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Rescue Medication Use - Change From Baseline in Mean Number of Days Used Per Week When Used | Visit 3 to Visit 4 the second 2 weeks of the study | -0.8 Days per Week | Standard Deviation 1.51 |
| Placebo | Rescue Medication Use - Change From Baseline in Mean Number of Days Used Per Week When Used | Visit 2 to Visit 3 the first 2 weeks of the study | -0.3 Days per Week | Standard Deviation 2.43 |
| Placebo | Rescue Medication Use - Change From Baseline in Mean Number of Days Used Per Week When Used | Visit 2 to Visit 4 the entire 4 weeks of the study | -1.1 Days per Week | Standard Deviation 1.95 |
| Levalbuterol MDI | Rescue Medication Use - Change From Baseline in Mean Number of Days Used Per Week When Used | Visit 3 to Visit 4 the second 2 weeks of the study | 0.1 Days per Week | Standard Deviation 2.57 |
| Levalbuterol MDI | Rescue Medication Use - Change From Baseline in Mean Number of Days Used Per Week When Used | Visit 2 to Visit 3 the first 2 weeks of the study | -0.8 Days per Week | Standard Deviation 2.22 |
| Levalbuterol MDI | Rescue Medication Use - Change From Baseline in Mean Number of Days Used Per Week When Used | Visit 2 to Visit 4 the entire 4 weeks of the study | -0.5 Days per Week | Standard Deviation 1.89 |
| Levalbuterol UDV | Rescue Medication Use - Change From Baseline in Mean Number of Days Used Per Week When Used | Visit 2 to Visit 3 the first 2 weeks of the study | -1.3 Days per Week | Standard Deviation 1.29 |
| Levalbuterol UDV | Rescue Medication Use - Change From Baseline in Mean Number of Days Used Per Week When Used | Visit 2 to Visit 4 the entire 4 weeks of the study | -1.1 Days per Week | Standard Deviation 0.73 |
| Levalbuterol UDV | Rescue Medication Use - Change From Baseline in Mean Number of Days Used Per Week When Used | Visit 3 to Visit 4 the second 2 weeks of the study | -1.0 Days per Week | Standard Deviation 0.94 |
Secondary
Rescue Medication Use - Change From Baseline in Mean Number of Doses Used Per Week
Time frame: Visit 2 to Visit 3 (the first 2 weeks of the study) , Visit 3 to Visit 4 (the second 2 weeks of the study), Visit 2 to Visit 4 (the entire 4 weeks of the study)
Population: Intent-to-Treat Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Rescue Medication Use - Change From Baseline in Mean Number of Doses Used Per Week | Visit 3 to Visit 4 the second 2 weeks of the study | -0.4 Doses per Week | Standard Deviation 3.56 |
| Placebo | Rescue Medication Use - Change From Baseline in Mean Number of Doses Used Per Week | Visit 2 to Visit 3 the first 2 weeks of the study | 0.0 Doses per Week | Standard Deviation 3.14 |
| Placebo | Rescue Medication Use - Change From Baseline in Mean Number of Doses Used Per Week | Visit 2 to Visit 4 the entire 4 weeks of the study | -0.2 Doses per Week | Standard Deviation 3.1 |
| Levalbuterol MDI | Rescue Medication Use - Change From Baseline in Mean Number of Doses Used Per Week | Visit 3 to Visit 4 the second 2 weeks of the study | 0.4 Doses per Week | Standard Deviation 2.83 |
| Levalbuterol MDI | Rescue Medication Use - Change From Baseline in Mean Number of Doses Used Per Week | Visit 2 to Visit 3 the first 2 weeks of the study | 0.1 Doses per Week | Standard Deviation 2.77 |
| Levalbuterol MDI | Rescue Medication Use - Change From Baseline in Mean Number of Doses Used Per Week | Visit 2 to Visit 4 the entire 4 weeks of the study | 0.3 Doses per Week | Standard Deviation 2.23 |
| Levalbuterol UDV | Rescue Medication Use - Change From Baseline in Mean Number of Doses Used Per Week | Visit 2 to Visit 3 the first 2 weeks of the study | 0.0 Doses per Week | Standard Deviation 0.77 |
| Levalbuterol UDV | Rescue Medication Use - Change From Baseline in Mean Number of Doses Used Per Week | Visit 2 to Visit 4 the entire 4 weeks of the study | 0.0 Doses per Week | Standard Deviation 0.96 |
| Levalbuterol UDV | Rescue Medication Use - Change From Baseline in Mean Number of Doses Used Per Week | Visit 3 to Visit 4 the second 2 weeks of the study | 0.1 Doses per Week | Standard Deviation 1.28 |
Secondary
Rescue Medication Use - Change From Baseline in Mean Number of Doses Used Per Week During Weeks When Used
Time frame: Visit 2 to Visit 3 (the first 2 weeks of the study), Visit 3 to Visit 4 (the second 2 weeks of the study), Visit 2 to Visit 4 (the entire 4 weeks of the study)
Population: Intent-to-Treat Population - subjects who used rescue medication at any time during the first 2 weeks of the study and who had used rescue medication at any time during baseline
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Rescue Medication Use - Change From Baseline in Mean Number of Doses Used Per Week During Weeks When Used | Visit 3 to Visit 4 the second 2 weeks of the study | -2.9 Doses per Week | Standard Deviation 7.64 |
| Placebo | Rescue Medication Use - Change From Baseline in Mean Number of Doses Used Per Week During Weeks When Used | Visit 2 to Visit 3 the first 2 weeks of the study | -2.1 Doses per Week | Standard Deviation 8.84 |
| Placebo | Rescue Medication Use - Change From Baseline in Mean Number of Doses Used Per Week During Weeks When Used | Visit 2 to Visit 4 the entire 4 weeks of the study | -2.1 Doses per Week | Standard Deviation 8.06 |
| Levalbuterol MDI | Rescue Medication Use - Change From Baseline in Mean Number of Doses Used Per Week During Weeks When Used | Visit 3 to Visit 4 the second 2 weeks of the study | 2.8 Doses per Week | Standard Deviation 6.27 |
| Levalbuterol MDI | Rescue Medication Use - Change From Baseline in Mean Number of Doses Used Per Week During Weeks When Used | Visit 2 to Visit 3 the first 2 weeks of the study | -0.6 Doses per Week | Standard Deviation 3.94 |
| Levalbuterol MDI | Rescue Medication Use - Change From Baseline in Mean Number of Doses Used Per Week During Weeks When Used | Visit 2 to Visit 4 the entire 4 weeks of the study | 1.8 Doses per Week | Standard Deviation 4.75 |
| Levalbuterol UDV | Rescue Medication Use - Change From Baseline in Mean Number of Doses Used Per Week During Weeks When Used | Visit 2 to Visit 3 the first 2 weeks of the study | -1.3 Doses per Week | Standard Deviation 2.08 |
| Levalbuterol UDV | Rescue Medication Use - Change From Baseline in Mean Number of Doses Used Per Week During Weeks When Used | Visit 2 to Visit 4 the entire 4 weeks of the study | -0.8 Doses per Week | Standard Deviation 1.56 |
| Levalbuterol UDV | Rescue Medication Use - Change From Baseline in Mean Number of Doses Used Per Week During Weeks When Used | Visit 3 to Visit 4 the second 2 weeks of the study | -0.8 Doses per Week | Standard Deviation 1.44 |
Secondary
Rescue Medication Use: Number of Subjects Using Rescue Medication During the Treatment Period
Number of subjects using rescue medication during the treatment period
Time frame: Visit 2 to Visit 3 (the first 2 weeks of the study) , Visit 3 to Visit 4 (the second 2 weeks of the study), Visit 2 to Visit 4 (the entire 4 weeks of the study)
Population: Intent-to-Treat Population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Rescue Medication Use: Number of Subjects Using Rescue Medication During the Treatment Period | Visit 3 to Visit 4 the second 2 weeks of the study | 20 Number of subjects |
| Placebo | Rescue Medication Use: Number of Subjects Using Rescue Medication During the Treatment Period | Visit 2 to Visit 3 the first 2 weeks of the study | 24 Number of subjects |
| Placebo | Rescue Medication Use: Number of Subjects Using Rescue Medication During the Treatment Period | Visit 2 to Visit 4 the entire 4 weeks of the study | 33 Number of subjects |
| Levalbuterol MDI | Rescue Medication Use: Number of Subjects Using Rescue Medication During the Treatment Period | Visit 3 to Visit 4 the second 2 weeks of the study | 20 Number of subjects |
| Levalbuterol MDI | Rescue Medication Use: Number of Subjects Using Rescue Medication During the Treatment Period | Visit 2 to Visit 3 the first 2 weeks of the study | 20 Number of subjects |
| Levalbuterol MDI | Rescue Medication Use: Number of Subjects Using Rescue Medication During the Treatment Period | Visit 2 to Visit 4 the entire 4 weeks of the study | 29 Number of subjects |
| Levalbuterol UDV | Rescue Medication Use: Number of Subjects Using Rescue Medication During the Treatment Period | Visit 2 to Visit 3 the first 2 weeks of the study | 14 Number of subjects |
| Levalbuterol UDV | Rescue Medication Use: Number of Subjects Using Rescue Medication During the Treatment Period | Visit 2 to Visit 4 the entire 4 weeks of the study | 20 Number of subjects |
| Levalbuterol UDV | Rescue Medication Use: Number of Subjects Using Rescue Medication During the Treatment Period | Visit 3 to Visit 4 the second 2 weeks of the study | 12 Number of subjects |